A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer - Full Text View

Sponsor:	Astellas Pharma Inc
Collaborator:	Agensys, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01016054

Purpose

This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.

Condition	Intervention	Phase
Carcinoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms	Biological: AGS-8M4 Drug: Pegylated liposomal doxorubicin (PLD) Drug: gemcitabine Drug: carboplatin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: Throughout the treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of PK variables [ Time Frame: Treatment Arm A: Weeks 1 and 3 of each cycle. Treatment Arm B: Week 1 of each cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits. ] [ Designated as safety issue: No ]
Incidence of anti-AGS-8M4 antibody formation [ Time Frame: Treatment Arm A: Day 1 of every other cycle and at Day 15 for the first cycle only. Treatment Arm B: Day 1 of every other cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits. ] [ Designated as safety issue: No ]
Changes in tumor status per RECIST [ Time Frame: Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks. ] [ Designated as safety issue: No ]
Change in CA-125 levels [ Time Frame: Treatment Arm A: Day 1 and Day 15 of each cycle. Treatment Arm B: Day 1 of each cycle. In addition, samples will be drawn at the Safety F/U. ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	October 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A. PLD plus AGS-8M4: Experimental Women with platinum resistent ovarian cancer	Biological: AGS-8M4 IV infusion Drug: Pegylated liposomal doxorubicin (PLD) IV infusion
B. Carboplatin and gemcitabine plus AGS-8M4: Experimental Women with platinum sensitive ovarian cancer	Biological: AGS-8M4 IV infusion Drug: gemcitabine IV infusion Drug: carboplatin IV infusion

Detailed Description:

All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
Subjects with either platinum resistant or platinum sensitive ovarian cancer
At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities

Exclusion Criteria:

Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
Use of any investigational drug within 30 days prior to screening
Prior monoclonal antibody therapy other than Avastin
Avastin administration within 90 days of screening
History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016054

Contacts

Contact: Agensys Clinical Research & Development

310-820-8029 ext 243

Clinical@agensys.com

Locations

United States, California
	Recruiting
Duarte, California, United States, 91010
United States, Maryland
	Not yet recruiting
Baltimore, Maryland, United States, 21231
United States, New York
	Not yet recruiting
New York, New York, United States, 10021

Sponsors and Collaborators

Astellas Pharma Inc

Agensys, Inc.

Investigators

Study Director:

Use Central Contact

Agensys, Inc.

More Information

No publications provided

Responsible Party:	Agensys, Inc ( VP, Clinical Research and Development )
Study ID Numbers:	2009001
Study First Received:	November 16, 2009
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT01016054 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Clinical Trial, Phase1
Combination Drug Therapy
pharmacokinetics
safety
Ovarian

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Gemcitabine

Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Pharmacologic Actions
Adnexal Diseases
Carcinoma
Neoplasms
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 08, 2010